Chronic Kidney Disease, Dialysis
Conditions
Keywords
Dose response relationship, immunity
Brief summary
The proposed study is a pilot study and a first step towards developing an optimized HPV vaccination strategy for girls who have CKD, or are on dialysis or have a kidney transplant.
Interventions
The HPV vaccination will be administered by intramuscular injection in three separate 0.5mL doses. The recommended schedule is a 3-dose series with dose #2 and #3 administered 2 and 6 months after dose #1, respectively. The minimum interval between dose #1 and #2 of the vaccine is 4 weeks. The minimum recommended interval between dose #2 and #3 of the vaccine is 12 weeks.
Sponsors
Merck Sharp & Dohme LLC
National Kidney Foundation, United States
Indiana University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 9-18-year-old girls who have CKD stages 3 or 4 (Glomerular filtration rates 15-59 mL/min/1.73m2). * 9-18-year-old girls who are on dialysis. * 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen. * Healthy 9-18-year-old girls
Exclusion criteria
* Pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.
Countries
United States
Outcome results
None listed